Cibrik 2007
ID: 5bfc51b47aaac8379380142f
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Estudio primario

No clasificado

Enteric‐coated mycophenolate sodium in combination with optimized neoral dosing, basiliximab, and steroids results in good efficacy and renal function in renal transplant recipients in the first six months

Revista American Journal of Transplantation
Año 2004
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Estudio primario

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Optimized Neoral C2 monitoring in combination with enteric‐coated mycophenolic acid, basiliximab and steroids is effective, safe and tolerable: 12‐month results of a multicenter, randomized, prospective trial

Revista Journal of the American Society of Nephrology
Año 2004
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Estudio primario

No clasificado

Safety and efficacy of EC‐MPS in combination with simulect and neoral in de novo renal transplant high‐risk recipients

Revista American Journal of Transplantation
Año 2005
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Estudio primario

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How much exposure is needed in the first week in patients receiving induction with basiliximab and enteric coated mycophenolate sodium?

Revista American Journal of Transplantation
Año 2005
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Estudio primario

No clasificado

Safety and tolerability of enteric coated mycophenolate sodium in combination with neoral and steroids in de novo kidney transplant recipients: 12 months analysis of a prospective trial

Revista Nephrology
Año 2005
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Estudio primario

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Tolerability of enteric coated mycophenolate sodium (EC‐MPS) in combination with neoral and steroids in de novo kidney transplant recipients: a 12 months prospective trial

Revista American Journal of Transplantation
Año 2005
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Estudio primario

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Treatment of high‐risk renal transplant recipients with EC‐MPS (Myfortic®) is safe and efficacious

Revista Journal of the American Society of Nephrology
Año 2005
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Estudio primario

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Renal function with cyclosporine C2 monitoring, enteric-coated mycophenolate sodium and basiliximab: a 12-month randomized trial in renal transplant recipients.

Revista Clinical transplantation
Año 2007
Enlaces Pubmed DOI
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BACKGROUND: Cyclosporine exposure, as estimated by the area under the curve (AUC), predicts outcomes in renal transplantation. Cyclosporine concentration at two h post-dose (C(2)) has been shown to be the most reliable, single-point surrogate marker for AUC. The objective of this study was to measure renal function beyond month 2 post-transplant using two different C(2) maintenance targets in combination with enteric-coated mycophenolate sodium (EC-MPS), corticosteroids, and basiliximab induction. METHODS: In this open-label, multicenter trial, renal transplant recipients entered one of two randomized groups at day 61 post-transplant: group A (higher-C(2) range) or group B (lower-C(2) range). RESULTS: Patients (164) were recruited, and 141 patients were entered the randomized groups (group A, n = 66; group B, n = 75). At 12 months, the mean calculated creatinine clearance was significantly greater in group B than in group A (79.2 vs. 71.0 mL/min, p < 0.05). Biopsy-proven acute rejection occurred in 14.7% patients in group B and in 24.2% patients in group A (n.s.). During the 12-month trial, 17.7% patients discontinued EC-MPS because of adverse events. Group B (44.0%) had fewer serious adverse events when compared with group A (62.1%; p = 0.04). Overall patient and graft survival were 99.4% and 95.7% respectively. Among 99 high-risk patients (i.e., African-American race, previous transplant, PRA >35% or >4 HLA mismatches), mean creatinine clearance at 12 months was 65.6 mL/min and biopsy-proven rejection occurred in 20.2% patients. CONCLUSIONS: Low cyclosporine C(2) levels are associated with improved renal function compared with higher C(2) levels when used in conjunction with EC-MPS, steroids and basiliximab induction. EC-MPS with low cyclosporine C(2) levels, corticosteroids and basiliximab provides excellent renal function with good efficacy even in high-risk patients.

Estudio primario

No clasificado

Efficacy and safety of enteric-coated mycophenolate sodium in renal transplant patients with diabetes mellitus: post hoc analyses from three clinical trials.

Revista Clinical transplantation
Año 2007
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To examine the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS, myfortic) in renal transplant patients with diabetes mellitus, six- and 12-month data from three clinical trials with EC-MPS (Studies B301, B302, and myPROMS) were analyzed post hoc. Studies B301 (de novo patients) and B302 (maintenance patients) followed a randomized double-blind design whereas myPROMS was an open-label study in de novo and maintenance renal transplant patients in which all patients received EC-MPS as part of their immunosuppressive regimen. In studies B301 and B302, diabetic patients were compared against mycophenolate mofetil (MMF, CellCept), the reference drug. For myPROMS, data from diabetic and non-diabetic patients were compared. In total, 246 diabetic patients receiving EC-MPS were analyzed. In study B301, the efficacy failure rate [biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up] in diabetics at 12 months was 17.6% (EC-MPS) vs. 26.2% (MMF), and of BPAR alone 14.7% vs. 19.0% (both n.s.). In de novo patients from myPROMS, the treatment failure rate was similar in diabetic (20.3%) and non-diabetic patients (27.1%), as was the incidence of BPAR (17.7% vs. 23.1%, both n.s.). The overall incidence, severity and pattern of AEs were comparable between EC-MPS and MMF in de novo patients. This was supported by the safety results assessed in maintenance patients (B302) indicating no increased safety risk with the use of EC-MPS in the diabetic patient population, if compared with MMF. Likewise, apart from a higher incidence of severe/serious infections in diabetics, the safety profile of EC-MPS was not different to non-diabetics in myPROMS. In conclusion, preliminary data suggest that EC-MPS in combination with cyclosporine (+/- steroids) can be used efficiently and safely for the prophylaxis of organ rejection in diabetic renal transplant patients. Moreover, diabetic patients can apparently be safely converted from MMF to EC-MPS. More data from prospective studies are needed to fully judge the efficacy and safety profile of EC-MPS in the diabetic transplant population.